This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or metastatic malignant tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, patients are intravenously infused with anti-mesothelin CAR T cells in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%).
China Meitan General Hospital
Beijing, China
RECRUITINGsafety of infusion of autologous anti-mesothelin CAR T cells as assessed by the incidents of treatment related adverse events per NCI CTCAE V4.0
incidents of treatment related adverse events per NCI CTCAE V4.0
Time frame: 2 years
treatment response rate of anti-mesothelin CAR T cells
Defined as the overall response rate (ORR), the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on the response evaluation criteria in solid tumor version 1.1 (RECIST1.1).
Time frame: 4 weeks
progression free survival
Time frame: 6 months
overall survival
Time frame: 2 years
proliferation of anti-mesothelin CAR T cells in patients
measured by quantitative PCR and flow cytometry
Time frame: 6 months
activation of anti-mesothelin CAR T cells in patients
measured by blood cytokine levels after CAR T cell infusion
Time frame: 6 months
persistence of anti-mesothelin CAR T cells in patients
measured by quantitative PCR and flow cytometry
Time frame: 1 year
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